BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMOSIL RECOMBIPLASTIN

    MDR report key: 657003 · Received December 15, 2005

    Report

    Report Number
    2431530-2005-00002
    Event Type
    Other
    Date Received
    December 15, 2005
    Report Date
    December 14, 2005
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GJS
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED THAT PT RESULTS WITH HEMOSIL RECOMBIPLASTIN REAGENT WERE ERRONEOUSLY PROLONGED FOR A PT BEING TREATED WITH DAPTOMYCIN. WHEN THE CUSTOMER SENT OUT A SAMPLE TO A REFERENCE LAB, THE PT RESULT CAME BACK IN OCTOBER 2005, AS NORMAL (12.4 SEC). THE CUSTOMER ALSO PERFORMED MIXING STUDIES. NOTE: AT THE TIME OF THE INCIDENT, DAPTOMYCIN WAS BEING TESTED FOR A NEW INDICATIONS FOR USE IN A PHASE III CLINICAL TRIAL. DUE TO CONSISTENTLY ELEVATED PT RESULTS AND THE RESULTS OF THE MIXING STUDY, THE PT WAS TREATED WITH FRESH FROZEN PLASMA AND NOVO SEVEN. TO CO'S KNOWLEDGE, THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOSIL RECOMBIPLASTIN PROTHROMBIN TIME TEST GJS INSTRUMENTATION LABORATORY CO. NA N0253072

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR